With the number of registered clinical trials increasing significantly each year, it’s not surprising to learn that the clinical trials supply and logistics market is predicted to grow exponentially in the years ahead. Recent data suggests that by 2030 this market will be valued at approximately $12.4 billion, up from $5.1 billion in 2020; this translates to a Compound Annual Growth Rate (CAGR) of 9.1% from 2021 to 2030.1 Such growth places huge pressure on drug discovery companies, CROs and CDMOs to find supply management solutions which ensure seamless, efficient delivery of clinical trial materials worldwide, whilst navigating the challenges of more complex study designs and the ever-evolving regulatory landscape. PCI Pharma Services’ clinicalSMART™ is one such solution.
What is clinicalSMART™?
PCI’s clinical Supply Management And Readiness Team (SMART) is a department of experienced Clinical Supplies professionals who manage clinical drug supply on behalf of clients. At the time of this writing, PCI’s clinicalSMART™ is supporting 74 clients and 214 studies globally. Designed with flexibility at its core, clinicalSMART™ is able to support sponsor requirements either throughout the entire study lifecycle, from protocol development through to the final destruction of materials, or at time points when sponsor teams require additional resources to supplement in-house supply management expertise. It does so by collating all key information from external parties (such as trial design, drug stability, and recruitment assumptions) and utilising in-house expertise to develop optimal supply strategies. Whether it’s working with clients’ internal teams in a consultative role, or assuming full ownership of supply chain management, clinicalSMART™ services are immediately available, preventing the need to recruit new staff, and delivering the agreed contracted hours per month as required by the client.
Established in 2016, clinicalSMART™ addressed the industry’s growing need for integrated clinical supply management services. At that time, the two highest ranking therapeutic areas in terms of clinical trial cost per patient were haematology and oncology, with a median cost of over $200k and over $100k respectively.2 As of September 2022, there were 174,669 registered interventional clinical trials using a drug or biologic therapies.3 Considering the sheer numbers involved here, any delays, miscommunications or errors in the clinical trials management process would be extremely costly in financial terms, not to mention the most important factor: the risks to the patients themselves.
Due to its initial successes, and a growing need from clients outside the US for the kinds of services offered by clinicalSMART™, the European and Asia Pacific team was established in 2019 to create a global team.